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EU says Novavax COVID shot must carry heart side-effect warning

By Natalie Grover and Ludwig Burger LONDON (Reuters) -The European Medicines Agency (EMA) is recommending Novavax (NASDAQ:NVAX)'s COVID-19 vaccine carry a warning of the...
EU says Novavax COVID shot must carry heart side-effect warning © Reuters. FILE PHOTO: A vial labelled "Novavax COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/Illustration

By Natalie Grover and Ludwig Burger

LONDON (Reuters) -The European Medicines Agency (EMA) is recommending Novavax (NASDAQ:NVAX)'s COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.

The heart conditions - myocarditis and pericarditis - should be listed as new side effects in the product information for the vaccine, Nuvaxovid, based on a small number of reported cases, the EMA said on Wednesday.

Novavax said no concerns about heart inflammations were raised during the clinical trials of Nuvaxovid and that more data would be gathered, adding that the most common cause of myocarditis is viral infections.

"We will work with the relevant regulators to assure our product information is consistent with our common interpretation of the incoming data," U.S. vaccine developer Novavax added.

In June, the U.S. Food and Drug Administration flagged a risk of heart inflammation from the Novavax vaccine.

Myocarditis and pericarditis were previously identified as rare side effects, mostly seen in young men, from groundbreaking messenger RNA (mRNA) vaccines made by Moderna (NASDAQ:MRNA) and the Pfizer (NYSE:PFE) and BioNTech alliance, with the vast majority of those affected recovering fully.

The EMA said on Wednesday it had asked Novavax to provide additional data on the risk of these side effects.

Last month, the EU agency identified severe allergic reactions as potential side effects of the vaccine.

Novavax was hoping that people who have opted not to take Pfizer and Moderna's vaccines would favour its shot because it relies on technology that has been used for decades to combat diseases including hepatitis B and influenza.

However, only around 250,000 doses of Nuvaxovid have been administered in Europe since its launch in December, according to the European Centre for Disease Prevention and Control.

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12-08-2022 17:12:30 (UTC+7)

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 EUR/USD1.0290↑ Sell
 GBP/USD1.2134↑ Sell
 USD/JPY133.43Neutral
 AUD/USD0.7100↑ Sell
 USD/CAD1.2766↑ Buy
 EUR/JPY137.29↑ Sell
 EUR/CHF0.9701↑ Sell
 Gold1,801.60↑ Sell
 Silver20.223↑ Sell
 Copper3.6740↑ Sell
 Crude Oil WTI94.34↑ Sell
 Brent Oil99.92↑ Sell
 Natural Gas8.639↑ Sell
 US Coffee C222.25↑ Sell
 Euro Stoxx 503,767.05↑ Sell
 S&P 5004,207.27Buy
 DAX13,757.80↑ Sell
 FTSE 1007,492.57↑ Sell
 Hang Seng20,175.62↑ Buy
 Small Cap 20001,975.26↑ Buy
 IBEX 358,434.73↑ Sell
 BASF44.153↑ Sell
 Bayer53.53↑ Sell
 Allianz181.44↑ Sell
 Adidas171.26↑ Sell
 Lufthansa6.574Sell
 Siemens AG111.94Neutral
 Deutsche Bank AG9.023↑ Buy
Mua/Bán 1 chỉ SJC
# So hôm qua # Chênh TG
SJC Eximbank6,620/ 6,720
(10/ 10) # 1,656
SJC HCM6,630/ 6,730
(10/ 10) # 1,666
SJC Hanoi6,630/ 6,732
(10/ 10) # 1,668
SJC Danang6,630/ 6,732
(10/ 10) # 1,668
SJC Nhatrang6,630/ 6,732
(10/ 10) # 1,668
SJC Cantho6,630/ 6,732
(10/ 10) # 1,668
Cập nhật 12-08-2022 17:12:32
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GBP27.761,8728.945,83
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KRW15,5018,89
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